On May 9, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2017, View Source [SID1234518945]).

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"This is an exciting time for FibroGen, as we prepare for an eventful second half of the year across our pipeline. In the third quarter of 2017, we anticipate reporting topline Phase 2 clinical trial results for pamrevlumab in idiopathic pulmonary fibrosis patients, and we are preparing to complete submission of the roxadustat China NDA for the treatment of anemia in non-dialysis and dialysis CKD patients," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are gratified by the support we received from new and current investors in our recent equity offering, which raised $115.1 million in net proceeds. This financing will support our plans to increase the number of studies and accelerate development in other anemia categories in China, including for roxadustat in anemias in certain oncology settings."

Recent Developments AND HIGHLIGHTS
U.S. Roxadustat for Anemia in Chronic Kidney Disease (CKD)

The independent data safety monitoring board (DSMB) recommended in April that all trials continue with no modifications to current protocols.
On track to submit the NDA for roxadustat in the U.S. in 2018.
U.S. Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Received approval from FDA to conduct Phase 3 study for the treatment of anemia in MDS. This study is planned to start in the third quarter of 2017.
China Roxadustat Anemia in CKD: Dialysis and Non-Dialysis

Positive Phase 3 results from two pivotal trials in China were announced on January 30, 2017.
On target for NDA submission in China in the third quarter of 2017.
China Roxadustat for Myelodysplastic Syndromes (MDS)

Received approval from the CFDA to undertake a Phase 2/3 study for the treatment of anemia in MDS. We plan to start this study in the fourth quarter of 2017.
Pamrevlumab in Idiopathic Pulmonary Fibrosis (IPF)

On track to report topline Phase 2 study results from a double-blind, placebo-controlled study, and a double-blind, active-controlled sub-study for the treatment of IPF in the third quarter of 2017.
Pamrevlumab in Pancreatic Cancer

Positive findings from an ongoing open-label, randomized Phase 1/2 study in locally advanced pancreatic cancer were presented at the 2017 Gastrointestinal Cancers Symposium in January.
Positive results from a prior Phase 1/2 trial were published online in January 2017 in the Journal of Cancer Clinical Trials.
Corporate and Financial Highlights

Net loss per basic and diluted share for the quarter ended March 31, 2017 was $0.52, as compared to $0.45 a year ago.
At March 31, 2017, FibroGen had $314.2 million of cash, restricted time deposits, cash equivalents, investments, and receivables.
In addition, we completed an equity financing on April 11, 2017 that generated $115.1 million in net proceeds.

On May 9, 2017 Compugen Ltd. (NASDAQ: CGEN), a therapeutic discovery company, reported financial results for the first quarter ended March 31, 2017 (Filing, Q1, Compugen, 2017, MAY 9, 2017, View Source [SID1234518944]).

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Anat Cohen-Dayag, Ph.D., CEO and President of Compugen, stated, "During this quarter we saw continuing scientific and therapeutic development advancements as well as business development progress in our four focus program areas:
·
COM701, an antibody drug candidate against PVRIG, a novel immune checkpoint target, with the potential to serve for both mono- and combination cancer immunotherapy;
·
COM902, an antibody drug candidate against TIGIT, with a strong biological rationale to work synergistically with COM701 and as a monotherapy treatment for cancer;
·
Multiple novel myeloid target programs for immuno-oncology aiming to expand the patient population responsive to checkpoint inhibitors; and
·
CGEN-15001, an Fc fusion protein candidate based on a novel immune checkpoint target for autoimmune diseases."

Dr. Cohen-Dayag continued, "Our on-going discussions with multiple potential partners indicate that these four program areas are aligned with key market needs and possess significant potential value. Furthermore, we believe each represents a unique and different value proposition for various potential partners and we further believe that at least one new industry partnership is achievable by the end of this year."

Financial Results
R&D expenses for the first quarter of 2017 were $6.7 million, compared with $6.8 million for the comparable period in 2016.

Net loss for the first quarter of 2017 was $8.7 million, or $0.17 per diluted share, compared with a net loss of $8.6 million, or $0.17 per diluted share, in the comparable period of 2016.

As of March 31, 2017, cash, cash related accounts, short-term bank deposits and restricted cash totaled $54.5 million, compared with $61.5 million at December 31, 2016. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its first quarter 2017 results today, May 9, 2017, at 10:00 a.m. ET. To access the live conference call by telephone, please dial 1-888-281-1167 from the US, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website through June 9, 2017.

On May 9, 2017 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the first quarter ended March 31, 2017 (Press release, Celldex Therapeutics, MAY 9, 2017, View Source [SID1234518942]).

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"In the first quarter of 2017, Celldex made considerable progress across our pipeline," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We continue to expect enrollment completion in our ongoing study of glembatumumab vedotin in triple negative breast cancer by the end of September, and we recently completed enrollment in the Phase 2 glembatumumab vedotin plus varlilumab combination cohort in checkpoint-refractory metastatic melanoma. Glemba’s target, gpNMB, is highly expressed in melanoma and triple negative breast cancer, among others, and is associated with more aggressive disease. We believe taking an antibody-drug conjugate approach to targeting gpNMB generates a potent cytotoxic effect within the tumor and its environment and may ultimately result in improved outcomes for patients."

"We also look forward to presenting data from two programs in oral sessions at ASCO (Free ASCO Whitepaper) in June—the Phase 2 single-agent study of glembatumumab vedotin in metastatic melanoma and the Phase 1 combination study of varlilumab and Opdivo."

Recent Highlights

Continued progress in METRIC enrollment: Celldex continues to expect that enrollment will be completed by the end of September 2017. METRIC is a Phase 2b randomized study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB.

Single-agent glembatumumab vedotin Phase 2 study in checkpoint-refractory metastatic melanoma accepted for oral presentation at ASCO (Free ASCO Whitepaper): Updated data from the single-agent cohort of the Phase 2 study will be presented in an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Enrollment recently completed in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Enrollment continues in the glembatumumab vedotin plus checkpoint inhibitor (Opdivo or Keytruda) arm in patients who failed prior checkpoint therapy, a population with limited treatment options.

Phase 1 varlilumab/Opdivo study accepted for oral presentation at ASCO (Free ASCO Whitepaper): Updated data from the Phase 1 portion of the varlilumab and Opdivo study will be presented in an oral presentation at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting in June. The Phase 2 portion of the combination study includes cohorts in colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, and is currently enrolling patients. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with Bristol-Myers Squibb to present data from the study at a future medical meeting. Data from the Phase 1 single-agent study of varlilumab in solid tumors were recently published in the Journal of Clinical Oncology.

Phase 1 study of CDX-0158 continues to enroll patients: This dose escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study continue to be expected by year-end 2017.

CDX-3379 advancing to Phase 2: The Company is currently finalizing plans for advancement into a Phase 2 study in combination with cetuximab in patients with cetuximab-resistant advanced head and neck squamous cell carcinoma.

Enrollment ongoing in Phase 1 study of CDX-014: The study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
First Quarter 2017 Financial Highlights and Updated 2017 Guidance

Cash position: Cash, cash equivalents and marketable securities as of March 31, 2017 were $167.0 million compared to $189.8 million as of December 31, 2016. The decrease was primarily driven by our first quarter cash used in operating activities of approximately $35.3 million which included a payment of $4.7 million in accrued amounts to a vendor of Kolltan. This obligation was assumed in the Kolltan acquisition. This decrease was partially offset by the receipt of $12.8 million from sales of our common stock under our Cantor agreement. At March 31, 2017, Celldex had 124.2 million shares outstanding.

Revenues: Total revenue was $1.5 million in the first quarter of 2017, compared to $1.3 million for the comparable period in 2016. The increase in revenue was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $25.8 million in the first quarter of 2017, compared to $27.4 million for the comparable period in 2016. The decrease in R&D expenses was primarily due to a decrease in Rintega product development expenses of $7.3 million, partially offset by increases in glembatumumab vedotin, CDX-0158 and CDX-3379 product development expenses of $1.8 million, $0.8 million and $0.7 million, respectively, and increases in personnel and facility costs related to the Kolltan acquisition.

G&A Expenses: General and administrative (G&A) expenses were $7.2 million in the first quarter of 2017, compared to $9.3 million for the comparable period in 2016. The decrease in G&A expenses was primarily due to a decrease in Rintega commercial planning costs of $2.0 million.

Loss on Fair Value Remeasurement of Contingent Consideration: In connection with the Kolltan Acquisition, we agreed to pay Kolltan’s stockholders milestone payments of up to $172.5 million in the event that certain specified preclinical and clinical development milestones related to Kolltan’s development programs and/or our development programs and certain commercial milestones related to Kolltan’s drug candidates are achieved. These milestone payments may be made in cash, in shares of our common stock or a combination of both, subject to NASDAQ listing requirements and provisions of the merger agreement. The range of estimated milestone payments is from zero, if no milestones are achieved, to $172.5 million if all milestones are met. We record the fair value of these obligations to pay additional milestone payments using various estimates, including probabilities of success, discount rates and amount of time until the conditions of the milestone payments are met. The $3.4 million loss on fair value remeasurement of contingent consideration relates to an increase in the estimate of the fair value of the contingent consideration primarily due to changes in discount rates and the passage of time.

Net loss: Net loss was $34.3 million, or ($0.28) per share, for the first quarter of 2017, compared to a net loss of $34.7 million, or ($0.35) per share, for the comparable period in 2016.

Financial guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2017 combined with the anticipated proceeds from future sales of our common stock under our Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2018; however, this guidance assumes we are able to and elect to pay future Kolltan contingent milestones, if any, in stock rather than cash.

Opdivo is a registered trademark of Bristol-Myers Squibb. Keytruda is a registered trademark of Merck Sharp & Dohme Corp.

On May 9, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2017 (Press release, Calithera Biosciences, MAY 9, 2017, View Source [SID1234518933]). As of March 31, 2017, cash, cash equivalents and investments totaled $207.1 million.

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"During the first quarter, we significantly strengthened the company’s financial position and we believe we are well positioned to execute on our strategy. Our collaboration and license agreement with Incyte maximizes the clinical and commercial potential of CB-1158, and we are pleased to have achieved the first milestone in March," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2017, we are on track to highlight new clinical data from each of our clinical programs at scientific meetings, including an oral presentation of CB-1158 data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, and multiple clinical updates on CB-839 in renal cell carcinoma and triple negative breast cancer in the second half of 2017. We also plan to present initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo."

First Quarter 2017 and Recent Highlights

CB-1158 Global Research, Development and Commercialization Collaboration with Incyte. In January 2017, Incyte and Calithera announced the global collaboration and license agreement for the research, development and commercialization of the first in class, small molecule arginase inhibitor CB-1158. Under the terms of the collaboration and license agreement, Calithera received an up-front payment of $45.0 million from Incyte in addition to an $8.0 million equity investment. CB-1158 entered clinical trials in September 2016 and a $12.0 million pharmacodynamic and pharmacokinetic milestone was achieved in March 2017. Payment of the milestone was received in the second quarter of 2017.

CB-1158 Data Accepted for Oral Presentation. Data from the Phase 1 solid tumor trial has been accepted for oral presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Clinical results to be presented in an oral presentation on June 5 include monotherapy data from Calithera’s Phase 1 trial in solid tumors.

CB-839 Enrollment Continues in Renal Cell Carcinoma and Triple Negative Breast Cancer. Calithera continues to enroll patients in combination trials in renal cell carcinoma and triple negative breast cancer, with updates from each of these trials expected in the second half of 2017. Phase 2 trials are expected to begin the second half of 2017 in both renal cell carcinoma and triple negative breast cancer. In addition, initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo are expected in the second half of 2017.

Completed Public Offering of Common Stock. In March 2017, Calithera completed an underwritten public offering of common stock, raising gross proceeds of $80.5 million.

At-the-Market progam. In the first quarter of 2017, Calithera received $38.0 million in gross proceeds from the sale of common stock pursuant to its at-the-market offering program.
Selected First Quarter 2017 Financial Results

Cash, cash equivalents and investments totaled $207.1 million at March 31, 2017, compared with $51.8 million at December 31, 2016. Calithera achieved a $12.0 million milestone under its global collaboration and license agreement with Incyte in March 2017, and payment was received in the second quarter of 2017.

Revenue was $4.2 million for the three months ended March 31, 2017 and represents the portion of deferred revenue recognized in the first quarter from the Company’s collaboration and license agreement with Incyte.

Research and development expenses were $6.6 million for the three months ended March 31, 2017, compared with $7.1 million for the same period in the prior year. The decrease of $0.5 million was primarily from the CB-1158 program, including Incyte’s co-funding of development costs, partially offset by an increase in the CB-839 program, including for Phase 2 start-up activities, as well as investment in our early stage research programs.

General and administrative expenses were $3.3 million for the three months ended March 31, 2017, compared with $2.6 million for the same period in the prior year. The increase of $0.7 million was primarily due to costs associated with the Incyte agreement and non-recurring expenses for the sublease of office and laboratory space in March 2017.

Net loss from operations for the three months ended March 31, 2017 was $5.6 million, or $0.22 per share.

Revised Financial Guidance for 2017

Calithera expects that its cash, cash equivalents and investments will be between $180 and $190 million at the end of 2017, exclusive of any funds arising from new collaborations or partnerships, achievement of additional milestones, additional equity financings or other new sources.

On May 9, 2017 Array BioPharma (Nasdaq: ARRY) reported top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma (Press release, Array BioPharma, MAY 9, 2017, View Source [SID1234518932]).

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The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with COMBO450 results in COLUMBUS Part 1. Part 2 was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.

"The totality of the COLUMBUS results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of binimetinib plus encorafenib as an attractive treatment option for patients diagnosed with BRAF-mutant melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School.

Ron Squarer, Chief Executive Officer at Array BioPharma noted: "The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS Part 2 once again demonstrates the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma. The results of Part 2 confirm the contribution of binimetinib to the combination."

Based on the strength of data from Part 1 and Part 2, Array is on track to file an NDA for COLUMBUS in June or July 2017.

About the Phase 3 COLUMBUS Study
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 study evaluating the efficacy and safety of the combination of binimetinib plus encorafenib to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the study. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive 45mg binimetinib plus 450mg encorafenib (COMBO450), 300mg encorafenib alone, or 960mg vemurafenib alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was a PFS comparison of COMBO450 versus vemurafenib. PFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the PFS of encorafenib monotherapy to that of COMBO450 and a comparison of overall survival (OS) for COMBO450 to that of vemurafenib alone.
In November 2016, results from Part 1 were presented at the Society for Melanoma Research Annual Congress. The study met its primary endpoint, with COMBO450 significantly improving PFS compared with vemurafenib alone. In the analysis of the primary endpoint, the mPFS for patients treated with COMBO450 was 14.9 months versus 7.3 months for patients treated with vemurafenib; hazard ratio (HR) 0.54, (95% CI 0.41-0.71, P<0.001). As part of the trial design, the primary analysis was based on a BICR of patient scans, while results by local review at the investigative site were also analyzed. The chart below outlines the mPFS results, as determined by both assessments, for COMBO450 versus vemurafenib, COMBO450 versus encorafenib, and encorafenib versus vemurafenib:



mPFS BICR

mPFS Local Review
COMBO450
vs.
Vemurafenib

COMBO450
Vemurafenib

COMBO450
Vemurafenib

14.9 months
7.3 months

14.8 months
7.3 months

HR (95% CI): 0.54 (0.41-0.71); P<0.001

HR (95% CI): 0.49 (0.37-0.64); P<0.001

COMBO450
vs.
Encorafenib

COMBO450
Encorafenib

COMBO450
Encorafenib

14.9 months
9.6 months

14.8 months
9.2 months

HR (95% CI): 0.75 (0.56-1.00); P=0.051

HR (95% CI): 0.68 (0.52-0.90); P=0.006

Encorafenib
vs.
Vemurafenib

Encorafenib
Vemurafenib

Encorafenib
Vemurafenib

9.6 months
7.3 months

9.2 months
7.3 months

HR (95% CI): 0.68 (0.52-0.90); P=0.007

HR (95% CI): 0.70 (0.54-0.91); P=0.008
COMBO450 was generally well-tolerated and reported adverse events (AEs) were overall consistent with previous bini/enco combination clinical trial results in BRAF-mutant melanoma patients. Grade 3/4 AEs which occurred in more than 5 percent of patients receiving COMBO450 included increased gamma-glutamyltransferase (GGT), increased blood creatine phosphokinase (CK), and hypertension. The incidence of AEs of special interest (toxicities commonly associated with commercially available MEK+BRAF-inhibitor treatments), for patients receiving COMBO450 included: rash (23 percent), pyrexia (18 percent), retinal pigment epithelial detachment (13 percent) and photosensitivity (5 percent).

In Part 2, 344 patients were randomized 3:1 to receive 45mg binimetinib plus 300mg encorafenib or 300mg encorafenib alone. Part 2 is designed to provide additional data to help evaluate the contribution of binimetinib to the combination of binimetinib and encorafenib. As the comparison of COMBO450 to encorafenib in Part 1 did not achieve statistical significance, the statistical analysis conducted in Part 2 is descriptive.
About BRAF-Mutant Melanoma
Melanoma is the fifth most common cancer among men and the sixth most common cancer among women in the United States, with more than 87,000 new cases and over 9,700 deaths from the disease expected in 2017. Up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Current marketed MEK/BRAF combination agents have a run rate approaching $1 billion in annual worldwide sales.

About Binimetinib & Encorafenib
MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial with encorafenib in combination with cetuximab with or without binimetinib in patients with BRAF V600E-mutant colorectal cancer.

Binimetinib and encorafenib are investigational medicines and are not currently approved in any country. Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S., Japan, Canada, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.